The present invention relates to ostomy devices of the type adapted to be adhesively affixed to the skin surrounding the stoma and more particularly to such a device which provides a means of controlling evacuation by internally sealing the stoma with a minimum amount of sealing pressure.
Certain surgical procedures known as colostomy, ileostomy and urostomy result in an opening in the abdominal wall, called a stoma, which permits waste discharge from the interior of a body cavity. Since the patient has no control over the waste discharge, it is often necessary for the patients who have undergone these surgical procedures to utilize an ostomy device to protect the stoma and collect the waste material as it is discharged.
Over the years, ostomy devices of a variety of different types and constructions have been utilized. Various materials and adhesives have been developed to increase the utility and wareability of the devices.
The basic device includes a collection receptacle or pouch connected to an adhesive coated faceplate which serves to mount the pouch to the body. The pouch includes first and, second thin film walls which are sealed by heat welding or the like along the periphery. The pouch has an inlet opening designed to be aligned with the stoma and may have an outlet for emptying material from the pouch. In single piece devices, the pouch is permanently affixed to the adhesive coated faceplate. In two-piece devices, the pouch is detachably mounted to the faceplate by coupling rings or the like, permitting the pouch to be replaced without removal of the faceplate each time.
The two-piece device requires a means for releasably mounting the pouch to the faceplate. One particularly successful structure takes the form of a pair of annular or ring-like rigid or semi-rigid plastic parts, one in the form of an axially extending rib and the other in the form of a channel into which the rib may be removably received and frictionally engaged.
These ostomy devices collect waste as it is discharged from the bowel but include no means for controlling when discharge takes place. One of the main objectives of ostomy appliances is to increase the freedom of mobility of the user and the ability of the user to lead a more normal life by participating in various activities. However, having discharge take place into the collection pouch in certain situations may cause embarrassment to the user because of the noise or smell or because of the increase in the size of the pouch. Accordingly, it is desirable to control when evacuation takes place so that it will not occur at times which may cause embarrassment.
It is possible to temporarily seal the stoma to prevent discharge at certain times. However, sealing the stoma normally requires the application of significant local pressure on the mucosal tissue, a result which must be avoided because high local pressure can abrade or otherwise damage the bowel tissue or can prevent blood flow to the tissue if the applied pressure exceeds local capillary pressure.
While it is desirable to prevent the flow of solid or semi-solid stool from the stoma, the same is not true with respect to flatus. As much as two-thirds of the volume of the bowel may be comprised of flatus. This gas must be released for user comfort and to maximize the time between evacuations.
It is also desirable that the sealing device be adapted to couple with a standard two-piece ostomy faceplate and thus be interchangeable with a standard two-piece ostomy pouch. Otherwise, the faceplate will have to be removed each time a new sealing device is mounted, a result which is to be avoided because repeated removal of the device can damage sensitive tissue and cause discomfort.
Those objectives are met in accordance with our invention through the use of a sealing device in the form of a balloon-like sealing member which is received within the bowel to seal the stoma against the discharge of solid or semi-solid stool.
The balloon-like sealing member exerts a low pressure (preferably a range between 10 mm Hg and 30 mm Hg) across a large area of the inner wall of the bowel proximal to the entry of the bowel through the abdominal wall. The sealing member is formed of a thin and flexible wall that is closed at one end and open at the other end. When the sealing member is pressurized, it expands like a balloon, forming a seal with a large contact area with the inner bowel wall. The flexibility of the member wall allows it to conform to the bowel wall. Based on preliminary laboratory test results, the device can prevent release of stool from the bowel with internal bowel pressures up of 50 mm Hg and above.
The sealing member wall is preferably made of a material that is also a good odor barrier. One such wall material would be polyurethane, although silicone rubber, thermoplastic elastomer or one of the wide variety of known multilayer barrier films would also be potentially good candidate materials.
The sealing member could have a variety of configurations to maximize seal effectiveness. One preferred shape would have a relatively large and bulbous proximal end to ensure full contact with the bowel wall in the region proximal to the abdominal wall. The overall diameter and length of the sealing member are also important, and would be selected to maximize effectiveness for users of a variety of body types and stoma shapes.
The sealing member reacts to temporary increases in internal bowel pressure by contracting slightly, thereby equalizing its internal pressure to the pressure in the bowel. The flexible and non-rigid nature of the member gives it complete freedom to move and conform to local changes in bowel pressure and shape.
By design, the seal created by the sealing member would also be slightly xe2x80x9cimperfectxe2x80x9d, such that flatus present at the interface between the exterior member wall and bowel wall would pass along that interface. Solid or semi-solid material, such as stool, would not be allowed to pass.
It is, therefore, a prime object of the present invention to provide a controlled evacuation ostomy device which includes an internal seal.
It is another object of the present invention to provide a controlled evacuation ostomy device with an internal seal in the form of an inflatable balloon-like sealing member that seals the stoma effectively while exerting only a minimum amount of sealing pressure.
It is another object of the present invention to provide a controlled evacuation ostomy device with an internal seal which prevents the discharge of solid and semi-solid stool but permits the release of flatus.
It is another object of the present invention to provide a controlled evacuation ostomy device with an internal seal which is deployed by insertion of the sealing member into the stoma, proximate to the abdominal wall.
It is another object of the present invention to provide a controlled evacuation ostomy device with an internal seal in which the sealing member is inserted into the bowel in the deflated condition and is thereafter inflated to conform to the shape of the inner wall of the bowel that surrounds it.
It is another object of the present invention to provide a controlled evacuation ostomy device with an internal seal in which the internal sealing pressure of the sealing member increases when exposed to an increase in internal bowel pressure.
It is another object of the present invention to provide a controlled evacuation ostomy device with an internal seal which is compatible with a standard two-piece ostomy device.
In accordance with one aspect of the present invention, an ostomy device is provided including a balloon-like member adapted to be received in the bowel and inflated to seal the stoma. The sealing member includes a flexible wall defining an opening. Cap means for retaining the member wall and closing the opening in the member are provided, as are means for adhering the cap means to the tissue proximate the stoma.
The sealing member preferably has a bulbous proximal end. The bulbous proximal end permits the wall of the member to fully contact the bowel.
The cap means has an inflation port. Means are provided for inflating the member through this port. Flexible tube means extend from the cap means and into the member. The flexible tube means defines an inflation channel connected to the inflation port. A one-way valve is associated with the inflation port.
The inflation means includes pump means with a nozzle. The nozzle is adapted to be received in the inflation port in the cap means. Relief valve means are associated with the pump means to prevent overinflation of the sealing member.
The means for adhering the cap to the tissue includes a faceplate. Means are provided for detachably mounting the cap means on the faceplate.
The faceplate includes a first engaging part. The detachable mounting means includes a second engaging part. The second engaging part defines an opening. The parts are adapted to inter-engage with the opening of the second engaging part aligned with the stoma.
The detachable mounting means also includes a member wall retaining part in the form of a disc with an opening. A waste collection receptacle is provided. The receptacle has a first inlet aligned with the second engaging part opening and a wall defining a second inlet. The portion of the receptacle wall proximate the second inlet is sealed to the retaining disc.
A channel is defined between the wall of the sealing member and the interior wall of the receptacle. Filter means are operably interposed between the channel and the environment. The filter means are preferably situated in the retaining disc.
Means are provided for detachably mounting the cap means on the second engaging part. The retaining disc is adapted to be received between the cap means and the second engaging part.
In accordance with another aspect of the present invention, an ostomy device is provided with a balloon-like member adapted to be received in the bowel and inflated to seal the stoma. The device includes a faceplate and means for adhering the faceplate to the tissue surrounding the stoma. The sealing member includes a flexible wall defining an opening. Cap means are provided for retaining the member wall and closing the opening in the member. The cap means includes an inflation port. Means are also provided for mounting the cap means on the faceplate.
Inflating means, in the form of a hand pump with a nozzle, are provided. The nozzle is adapted to be removably connected to the inflation port. The inflating means can alternatively be incorporated as integral feature in the cap.
A waste collection receptacle is operably interposed between the cap means and the faceplate. The cap means mounting means includes means for detachably engaging the faceplate and means for detachably mounting the cap means on the faceplate engaging means. The faceplate engaging means also includes a member retaining disc. The receptacle wall is affixed to the retaining disc. The retaining disc includes filter means through which flatus is vented to the environment.
The faceplate includes a first engaging part. The faceplate engaging means includes a second engaging part. These parts inter-exchange to detachably mount the cap on the faceplate.
The cap means also includes a flexible tube with an inflation channel. The tube is received in the member. A one-way valve is associated with the inflation channel.